1. Field of Invention
The invention relates to sterile medical procedure kits.
2. Description of Related Art
Pre-sterilized medical procedure kits are known and used for various medical operating procedures. Such sterilized procedure kits are provided with a plurality of components used in connection with a particular surgical procedure. These kits have been used, for example, as suture or wound closure kits, or other procedural kits, including tools necessary to complete a desired surgical procedure, such as endoscopic or laparoscopic surgery. Such kits include components that must be sterilized before or during packaging and must be maintained in a sterile condition until used.
Sterilization of medical procedure kits and/or its packaging are accomplished by various methods. These methods include chemical, physical, and/or irradiation methods. Examples of chemical methods include exposure to ethylene oxide or hydrogen peroxide vapor. Examples of physical methods include sterilization by heat. Examples of irradiation methods include gamma irradiation, electron beam irradiation, and microwave irradiation.
U.S. Pat. No. 4,522,302 to Paikoff discloses one known pre-sterilized medical procedure kit package within an outer package wrap. The kit includes two compartments, pre-sterilized by ethylene oxide and wrapped within an inner package wrap. A first compartment contains essential medical procedure components, which are subjected to ethylene oxide sterilization. A second compartment contains a vial with an agent incompatible with ethylene oxide sterilization, such as a vial with a rubber stopper. The vial is separately heat sterilized and then sealed inside an ethylene oxide impermeable container and placed in the second compartment prior to exposure of the complete kit to ethylene oxide sterilization.
Another known procedure kit can be found in U.S. Pat. No. 4,523,679 to Paikoff et al., which also discloses a pre-sterilized medical procedure kit with at least two compartments. A larger compartment includes medical components for a particular procedure. A second smaller compartment can have a cavity open from two sides and sealable by barrier layers. In use, the medical components are placed in the larger compartment and the barrier layers are provided on the smaller compartment while the kit is exposed to ethylene oxide sterilization. Then, the kit is removed to a sterile environment and the barrier layers are removed and a second component, made of rubber and heat sterilized elsewhere, is sealed in the smaller compartment with new sterile barrier layers. The package is then placed in a sterile outer wrap and sealed. This allows a kit to include a component that is incompatible with ethylene oxide sterilization.
A known surgical suture kit is commercially available from Inlet Medical Inc. This kit includes a disposable suture passer, a pilot suturing guide, and braided sutures. Such a kit is intended for use in securing trocar wounds made during laparoscopic surgery.
Other suture procedure kits can be found in U.S. Pat. No. 5,350,060 to Alpern; U.S. Pat. No. 5,615,766 to Gemma, Jr. et al.; U.S. Pat. No. 5,335,775 to Scanlon et al.; and U.S. Pat. No. 5,282,533 to Holzwarth et al.
Pre-packaged procedure kits including instrumentation for endoscopic surgery can be found in U.S. Pat. Nos. 5,315,985 and 5,144,942, both to Decarie et al.; and U.S. Pat. No. 5,375,717 to Roshdy. The Decarie et al. patents provide a procedure kit useful in performing laparoscopic or endoscopic surgery, including a trocar assembly, an obturator, a sleeve member, a cutting device, a stapling device, a dissector, a gripping device, a catheter, and the like.
U.S. Pat. No. 5,874,044 to Kotzev discloses sterilization of cyanoacrylate having a package containing the sterile cyanoacrylate. The package is taught to be heat-resistant up to the sterilization temperature, while providing an adequate barrier to moisture and being cyanoacrylate-compatible. The sterilization is achieved using heat sterilization or radiation. Kotzev appears to recognize and teach that cyanoacrylate formulations have reduced shelf life after being exposed to most types of sterilization.
U.S. Pat. No. 5,881,536 to Mxc3xcller-Wille et al. discloses a method and device for sterile packaging of a substance in a container, whereby the substance is unable to stand the same sterilization process as the one to which the container is subjected. The method includes sterilizing the container (not containing the substance) while the container is enclosed in an outer package so that the container becomes internally and externally sterile; sterilizing the substance with a different sterilizing process; and inserting the substance into the container without contaminating the container or the substance.
Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the xcex1-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the xcex1-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues.
It is known that monomeric forms of xcex1-cyanoacrylates are extremely reactive, polymerizing rapidly in the presence of even minute amounts of an initiator, including moisture present in the air or on moist surfaces such as animal (including human) tissue. Monomers of xcex1-cyanoacrylates are anionically polymerizable or free radical polymerizable, or polymerizable by zwitterions or ion pairs to form polymers. Once polymerization has been initiated, the cure rate can be very rapid.
Medical applications of 1,1-disubstituted ethylene adhesive compositions include use as an alternate or an adjunct to surgical sutures and/or staples in wound closure, as well as for covering and protecting surface wounds such as lacerations, abrasions, burns, stomatitis, sores, minor cuts and scrapes, and other wounds. When an adhesive is applied to surfaces to be joined, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond.
No known commercial sterilized procedure kits (particularly surgical procedure kits or wound closure kits) include a medical adhesive, such as a 1,1 -disubstituted ethylene monomer (cyanoacrylate). It is believed that this may in part be due to factors involving sterilization. That is, many medical adhesives degrade to below a satisfactory level after multiple exposures to sterilization processes. However, many known procedure kits require multiple sterilization procedures to achieve sterilization of all components within the kit.
There is a need for a medical procedure kit that includes a medical adhesive useful in connection with at least a portion of a medical or surgical procedure, such as wound closure. The addition of such an adhesive in a surgical kit would greatly benefit the convenience of medical procedures, as adhesive wound closure products, such as Dermabond(copyright) adhesive, available from Closure Medical Corporation of Raleigh, N.C. can be readily applied to a wound site and are extremely effective as part of a wound closure system. Such a procedure kit is particularly useful when packaged with a procedure kit for laparoscopic or endoscopic surgery. However, heretofore, such a procedure kit has not been realized in the commercial market.
Applicant has overcome the above and other problems by the present invention, which provides a medical adhesive as part of a sterilized surgical procedure kit.
According to one aspect of the invention, all components of the procedure kit but the adhesive and applicator are packaged in kit form and sterilized. Then, the adhesive and optionally an adhesive applicator are separately sterilized and packaged, with the resultant two sterilized packages being associated so as to provide one convenient, combined medical procedural kit that can be brought into an operating room or other sterile environment to be used.
According to another aspect of the invention, the adhesive and optionally an adhesive applicator are sterilized and placed in a sterilization barrier, such as a foil barrier impervious to a certain type of sterilization procedure, and the sterilization barrier containing the adhesive is provided along with remaining components of the procedure kit in kit form and subsequently exposed to sterilization, such as exposure to ethylene oxide, to sterilize the entirety of the contents. In this embodiment, as the adhesive is contained within the sterilization barrier, the adhesive is not subjected to multiple sterilization processes and thus may prevent possible degradation or polymerization due to over exposure to sterilization processes.
According to yet another aspect of the invention, the adhesive and applicator are placed along with all remaining components into the procedure kit, and are subsequently subjected to one or more sterilization processes. However, in accordance with this aspect, the medical adhesive and applicator are formulated to withstand the applied sterilization process without degradation to below product specification parameters. That is, there is substantially no initiation of polymerization of monomeric liquid adhesive compositions that would substantially affect the utility or shelf-life of the monomer or monomers.